Senior Systems Engineer

Amgen • Thousand Oaks, CA

61d

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Systems Engineer What you will do Let’s do this! Let’s change the world! The Senior Systems Engineer leads development activities within a cross-functional program team to create the technical content, performance, intellectual property and quality deliverables of a combination product (device/biologic combination) development program. This role leads the capture of user needs and translation into system requirements and is also responsible for the functional decomposition and allocation to subsystems. The Senior Systems Engineer owns respective systems engineering deliverables and ensures that the quality targets are satisfied, identifies and communicates technical risks and coordinates risk retirement activities on the program. Also, maintains close cross-functional interaction within Amgen to deliver on customer satisfaction through high product quality.

Requirements

• High school diploma / GED and 10 years of directly related engineering experience OR Associate’s degree and 8 years of directly related engineering experience OR Bachelor’s degree and 4 years of directly related engineering experience OR Master’s degree and 2 years of directly related engineering experience OR Doctorate degree

Nice To Haves

• 6+ years of progressive experience as an engineer within the appropriate field of study.
• 5+ years of experience in product development working with mechanical medical devices, ideally combination products (device/biologics combination).
• Formal Systems Engineering training/certification.
• Demonstrated applied lean 6 Sigma competency.
• Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues.
• Demonstrated broad exposure to HW/SW/Systems design and technical depth in one or more engineering disciplines (Electrical, Mechanical, Software, etc.)
• Leadership ability for system-level design and testing (Verification and Validation testing of System Level Performance).
• Deep knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position.
• Familiar with the following standards: Needle-based Injection Systems – ISO 11608-1 Prefilled Syringe Systems – ISO 11040 Quality Management – ISO 13485 Risk Management – ISO 14971 EU Medical Device Regulation
• Strong background in documenting requirements and providing traceability documentation for regulatory approval – Dassault 3DS, DOORS or other similar electronic requirements management software.
• Practical experience in configuration management and change control process/requirements – CCB (change control board), CIT (change implementation team) concepts.
• Strong interpersonal skills.

Responsibilities

• Provide leadership and support for requirements management for large or complex development programs.
• Lead the development, execution and review of requirements (within an electronic requirements management system), design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects.
• Lead the creation and assessment of product requirements to determine technical coverage and proper integration different subsystems of combination products through consideration of the system as a whole, rather than individual components of the system.
• Work cross-functionally with individuals and project teams in Marketing, Operations, Manufacturing and Development.
• Oversight of characterization or feasibility testing as well as computer simulations.
• Utilize project planning and monitoring methods to ensure timely completion.
• Review and approve completed design documentation.
• Mentor junior engineers

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees